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Type 1 diabetes mellitus

Part of Type 1 Diabetes

14 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Type 1 diabetes mellitus

350 trials tracked for Type 1 diabetes mellitus: 101 in phase 3 or 4 and 46 with published results. The most-cited published study has 493 citations.

350Trials tracked
101Phase 3 & 4
0Recruiting
46With published results
Phase distribution
Phase 4 25 Phase 3 76 Phase 2 64 Phase 1 39 Other / NA 146
  1. Phase 3 The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus Completed · 493 cited
  2. Phase 3 Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2) Completed · 365 cited
  3. Phase 3 Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3) Completed · 362 cited
  4. Phase 3 REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) Completed · 356 cited
  5. Phase 3 The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes Completed · 345 cited
  6. Phase 3 Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab Completed · 269 cited
Show 44 more trials
  1. Phase 3 The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes Completed · 262 cited
  2. Phase 3 Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy Completed · 234 cited
  3. Phase 3 Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus Completed · 213 cited
  4. Phase 3 A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes Completed · 206 cited
  5. Phase 3 A Study in Participants With Type 1 Diabetes Mellitus Completed · 186 cited
  6. Phase 3 Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy Completed · 186 cited
  7. Phase 3 A Study in Participants With Type I Diabetes Mellitus Completed · 186 cited
  8. Phase 3 Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes Completed · 178 cited
  9. Phase 3 Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease Completed · 135 cited
  10. Phase 3 Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes Completed · 122 cited
  11. Phase 3 A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) Completed · 112 cited
  12. Phase 3 Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes Completed · 80 cited
  13. Phase 3 Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes Completed · 79 cited
  14. Phase 3 Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes Completed · 78 cited
  15. Phase 3 The Bihormonal iLet Bionic Pancreas Feasibility Study Completed · 74 cited
  16. Phase 3 Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes Completed · 71 cited
  17. Phase 4 Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Completed · 69 cited
  18. Phase 3 Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes Completed · 69 cited
  19. Phase 3 Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes Completed · 56 cited
  20. Phase 3 A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects Completed · 54 cited
  21. Phase 3 Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes Completed · 52 cited
  22. Phase 4 Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) Completed · 44 cited
  23. Phase 3 FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump Completed · 37 cited
  24. Phase 3 Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine Completed · 33 cited
  25. Phase 3 Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics Completed · 32 cited
  26. Phase 3 Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus Completed · 28 cited
  27. Phase 4 Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients Completed · 23 cited
  28. Phase 3 G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes Completed · 22 cited
  29. Phase 3 Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics Completed · 22 cited
  30. Phase 3 A Study of LY900014 in Participants With Type 1 Diabetes Completed · 14 cited
  31. Phase 3 Mylan Insulin Aspart Study Completed · 9 cited
  32. Phase 3 A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003) Completed · 9 cited
  33. Phase 3 G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes Completed · 8 cited
  34. Phase 4 Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. Completed · 6 cited
  35. Phase 3 A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus Completed · 6 cited
  36. Phase 4 Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings Completed · 5 cited
  37. Phase 4 Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency Completed · 4 cited
  38. Phase 3 Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine Completed · 3 cited
  39. Phase 3 A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Completed · 3 cited
  40. Phase 3 Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults Completed · 2 cited
  41. Phase 4 Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon Completed
  42. Phase 4 Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus Completed
  43. Phase 4 Sitagliptin Dose Determination Study Completed
  44. Phase 4 Detemir: Role in Type 1 Diabetes Completed

Showing the 50 most-cited and recently-updated of 350 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Type 1 diabetes mellitus: what the trials found

Several insulin formulations and delivery systems have been evaluated for their impact on glycemic control. Insulin glargine (300 U/ml) demonstrated non-inferiority in time in range (TIR) of 70-180 mg/dL compared to a reference, while also showing significant improvements in the coefficient of variation (CV%) 10. A separate study on insulin glargine showed consistent results for both time in range and time in serious hypoglycemia 12. Insulin degludec was associated with significantly improved time in range (70-140 mg/dl and 70-180 mg/dl) and lower mean glucose levels compared to baseline 11.

Advanced insulin delivery systems, such as the Tandem t:slim X2 with HCL or PLGS, showed low rates of hypoglycemia (under 54 mg/dL) and high percentages of time in range 9. The use of Technosphere insulin was associated with increased time in range, reduced post-prandial glucose excursions, and decreased glucose variability 8. Rapid-acting insulin combined with rHuPH20 pre-treatment demonstrated consistent times to reach specific glucose reduction targets 18.

Other pharmacological interventions include sitagliptin, which was associated with better targeted blood glucose levels 21, and SGLT2 inhibitors, which were shown to result in lower capillary blood beta-hydroxybutyrate levels during outpatient care 13. Rapid-acting insulin options like glulisine and Fiasp were evaluated for post-prandial management and time in range respectively [14, 17]. Afrezza was also assessed regarding hypoglycemia rates 15.

Recent results — preliminary, needs further review

  • Control-IQ technology 2.0 showed low percentages of time below 54 mg/dL (0.1% to 0.2%) and moderate time in range between 70-140 mg/dL (~51-53%) 1.
  • The EnMPC AP Controller demonstrated high time in range (81%) and zero percent of time below 54 mg/dL 3.
  • Omnipod 5 System showed a range of time in range results (39.42% to 65.26%) with low rates of hypoglycemia 5.
  • The t:slim X2 with Tandem Freedom Algorithm demonstrated high time in range (~56-61%) and very low rates of hypoglycemia 7.
  • Continuous Glucose Monitoring (CGM) was associated with a significant reduction in Hemoglobin A1c over 3 months (-0.9, p=0.03) and a reduction in depression scores 6.

For the clinician treating this condition

  • Multiple insulin formulations, including glargine and degludec, have demonstrated consistent efficacy in maintaining time in range (TIR) and reducing glucose variability.
  • Advanced automated insulin delivery systems and specific technologies (e.g., Control-IQ, EnMPC, Tandem Freedom Algorithm) consistently demonstrate low rates of hypoglycemia while maintaining target ranges.
  • Continuous Glucose Monitoring is associated with significant improvements in both clinical markers (HbA1c) and patient psychological well-being.

AI synthesis of 14 cited trials, updated Jun 20, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.

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Questions about Type 1 diabetes mellitus

Can cervical cancer treatment cause new Type 1 diabetes and diabetic ketoacidosis?

Yes, certain cervical cancer treatments, especially immune checkpoint inhibitors like cadonilimab, can trigger new-onset type 1 diabetes and diabetic ketoacidosis, though this is a rare but serious side effect.

Full answer →
Can integrative therapies help improve blood sugar control in Type 1 diabetes?

Integrative therapies like yoga and naturopathy may offer modest adjunctive benefits for blood sugar control in Type 1 diabetes, but evidence is limited and they should complement, not replace, standard insulin therapy.

Full answer →

All Type 1 diabetes mellitus Articles